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| Senior Medical Officer (Clinical Investigator) - 01 post |
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| Responsibilities: |
| - conducting BA/BE studies |
| - communicating with ethics committees for approval for clinical studies |
| - coordinating with other study personnel |
| - training of study personnel |
| - assist head clinical operation in day to day activities of clinical section |
| Eligibility: MD pharmacology with 1-2 years of experience in BA/BE studies or MBBS with 3-5 years experience in BA/BE studies |
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| Quality Control (Clinical Section) - 01 post |
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| Responsibilities: |
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monitoring the BA/BE studies |
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reviewing the data generated in BA/BE studies |
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reviewing the facilities and procedures to meet the guidelines |
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reviewing protocol and other IEC related documents |
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assist head clinical for implementing SOPs and GCP |
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conducting training for the study staff |
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assuming any other responsibility as per the need of the organization |
| Eligibility: M. Pharm/ Masters in life sciences with 1-2 years experience in clinical research |
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| Research Officer (Quality Assurance) - 01 Post |
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| Responsibilities: |
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Schedule and conduct of periodic internal audits of the facility and systems |
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Review of SOPs for suitability of existing procedures and updation |
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Conduct of regular study audits (clinical, bioanalytical, PK and statistical) during initiation, in-process and reporting phase of bioequivalence projects |
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Preparation of the facility for external audits & inspections |
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Organsing archival and retrieval of all technical records of CRO |
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Review of method validation, chromatographic data and final study reports for QA authentication as per regulatory requirements |
| Eligibility: M. Pharm/ Masters in life sciences with 1-2 years experience in quality assurance/clinical research. |